Pediatric Acute Myeloid LeukemiaNCT02794207
Home or Away From Home - Descriptive Interviews (Aim 2)
An observational study of Pediatric Acute Myeloid Leukemia, run by Children's Hospital of Philadelphia at 11 sites in United States.
Trial summary
The primary objectives of this study are to identify what outcomes related to the management of neutropenia are most important to children with AML and their caregivers. Patients who have completed treatment for AML and their caregivers will be interviewed in order to better understand the impact of neutropenia… Read more about this study
- Who is it for?
- Ages 8 to 22 years
- Conditions the study is for
- Pediatric Acute Myeloid Leukemia
- How many people
- 86 participants
- Where
- 11 sitesUnited States
- Study dates
- Aug 2015to 3 Jan 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Study population will consist of patients who are less than 19 years of age at the time of diagnosis (and their caregivers) receiving or having received chemotherapy for AML.
Who may be able to join
- To be enrolled in this study, patients must be:
- A male or female between 8 and 22 years of age
- Have a diagnosis of AML
- Be either within 6-12 months of completion of the second course of chemotherapy for AML OR out of AML therapy for up to 3 years
- To be enrolled in this study, caregivers must be:
- A male or female 18 years of age or older
Show all 10Show fewer
- Be the parent/legal guardian of a child that meets the inclusion criteria detailed above (#1) OR
- Be the parent/legal guardian of a male or female child younger than 8 years of age with AML and who is within 6-12 months of completion of their second course of chemotherapy
- Be the parent/legal guardian of a male or female child younger than 8 years of age with AML and who is out of AML therapy for up to 3 years
- Parental/guardian informed consent and, if appropriate, child assent.
Who cannot join
- 1) None
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Children's Medical Center of Dallas
Dallas, Texas, 75235
Children's Hospital of Michigan
Detroit, Michigan, 48201
Texas Children's Hospital
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Lucile Packard Children's Hospital
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Primary Children's Hospital
Salt Lake City, Utah, 84132
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Home or Away From Home: Patient-Centered Outcomes Related to the Management of Neutropenia Which Are Most Important to Children With AML and Their Caregivers
The primary objectives of this study are to identify what outcomes related to the management of neutropenia are most important to children with AML and their caregivers. Patients who have completed treatment for AML and their caregivers will be interviewed in order to better understand the impact of neutropenia management on children with AML and their families. The primary outcome of these interviews is to identify patient-centered outcomes related to neutropenia management to include in a subsequent comparative-effectiveness analysis. Investigators will use these data to develop a structured survey for administration to prospectively identified patients in subsequent studies.
Read the detailed description
Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens that result in periods of profound neutropenia leaving patients susceptible to severe infectious complications. There are little clinical data to inform whether management of neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting. Further, no studies have been conducted that assess the impact of neutropenia management strategy on the quality of life of pediatric patients with AML. Given that infectious complications are the leading cause of treatment related mortality among AML patients, it is important to identify the neutropenia management strategy that will lead to the best clinician- and patient- identified outcomes in order to improve the care of these patients.
This is a qualitative interview study where interviews of patients and/or caregivers will be performed. Participants will be patients less than 19 years of age at diagnosis (and their caregivers) receiving or having received chemotherapy for AML from eleven participating pediatric hospitals across the United States. Participants (children and caregivers) will be interviewed in an effort to develop a survey that captures patient- and caregiver- identified outcomes related to neutropenia management.
- Conditions
- Pediatric Acute Myeloid Leukemia
- Keywords
- Pediatric, Cancer, AML, Qualitative Interview
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants | One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of the participant's illness and treatment. Several close-ended questions regarding participant's thoughts on potential outcomes will also be included. | |
| Caregivers | One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of their child's illness and treatment. Several close-ended questions regarding participant's thoughts on their child's potential outcomes will also be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Issues Related to Type of Neutropenia Management That Are Most Important to Children and Their Caregivers.
Issues related to type of neutropenia management are not quantifiable. All interviewees gave unique responses to issues related to neutropenia management, and themes were identified after all interviews were conducted and analyzed.
Measured: One qualitative semi-structured interview was conducted post-neutropenia management. The interview lasted about 30-45 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startAug 2015
- Primary completion3 Jan 2017
- Study completion3 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Primary Children's Hospital, Texas Children's Cancer Center, Children's Healthcare of Atlanta, C.S. Mott Children's Hospital, Children's Medical Center Dallas, Arkansas Children's Hospital Research Institute, Ann & Robert H Lurie Children's Hospital of Chicago, Children's Hospital of Michigan, Lucile Packard Children's Hospital, Seattle Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Richard Aplenc, MD, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794207
- Sponsor's protocol ID
- 15-012082
- Status last verified
- Jan 2020
- First submitted
- 13 May 2016
- Last updated
- 27 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Only aggregate level data will be shared with the study sponsor Patient-Centered Outcomes Research Institute (PCORI).
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home or Away From Home: Patient-Centered Outcomes Related to the Management of Neutropenia Which Are Most Important to Children With AML and Their Caregivers
- ClinicalTrials.gov ID
- NCT02794207
- Acronym / sponsor ID
- 15-012082
- Conditions
- Pediatric Acute Myeloid Leukemia
- Keywords
- Pediatric, Cancer, AML, Qualitative Interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Primary Children's Hospital, Texas Children's Cancer Center, Children's Healthcare of Atlanta, C.S. Mott Children's Hospital, Children's Medical Center Dallas, Arkansas Children's Hospital Research Institute, Ann & Robert H Lurie Children's Hospital of Chicago, Children's Hospital of Michigan, Lucile Packard Children's Hospital, Seattle Children's Hospital
- Study start
- Aug 2015 (actual)
- Primary completion
- 3 Jan 2017 (actual)
- Study completion
- 3 Jan 2017 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Posted 27 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to identify what outcomes related to the management of neutropenia are most important to children with AML and their caregivers. Patients who have completed treatment for AML and their caregivers will be interviewed in order to better understand the impact of neutropenia management on children with AML and their families. The primary outcome of these interviews is to identify patient-centered outcomes related to neutropenia management to include in a subsequent comparative-effectiveness analysis. Investigators will use these data to develop a structured survey for administration to prospectively identified patients in subsequent studies.
Detailed description
Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens that result in periods of profound neutropenia leaving patients susceptible to severe infectious complications. There are little clinical data to inform whether management of neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting. Further, no studies have been conducted that assess the impact of neutropenia management strategy on the quality of life of pediatric patients with AML. Given that infectious complications are the leading cause of treatment related mortality among AML patients, it is important to identify the neutropenia management strategy that will lead to the best clinician- and patient- identified outcomes in order to improve the care of these patients.
This is a qualitative interview study where interviews of patients and/or caregivers will be performed. Participants will be patients less than 19 years of age at diagnosis (and their caregivers) receiving or having received chemotherapy for AML from eleven participating pediatric hospitals across the United States. Participants (children and caregivers) will be interviewed in an effort to develop a survey that captures patient- and caregiver- identified outcomes related to neutropenia management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants | – | –One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of the participant's illness and treatment. Several close-ended questions regarding participant's thoughts on potential outcomes will also be included. |
| Caregivers | – | –One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of their child's illness and treatment. Several close-ended questions regarding participant's thoughts on their child's potential outcomes will also be included. |
Who may qualify
- Ages
- 8 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Study population will consist of patients who are less than 19 years of age at the time of diagnosis (and their caregivers) receiving or having received chemotherapy for AML.
Key inclusion criteria (10 listed)
- To be enrolled in this study, patients must be:
- To be enrolled in this study, caregivers must be:
- Parental/guardian informed consent and, if appropriate, child assent.
Key exclusion criteria (1 listed)
- 1) None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Issues Related to Type of Neutropenia Management That Are Most Important to Children and Their Caregivers.
Time frame: One qualitative semi-structured interview was conducted post-neutropenia management. The interview lasted about 30-45 minutes.
Issues related to type of neutropenia management are not quantifiable. All interviewees gave unique responses to issues related to neutropenia management, and themes were identified after all interviews were conducted and analyzed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Only aggregate level data will be shared with the study sponsor Patient-Centered Outcomes Research Institute (PCORI).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Aplenc, MD, PhD principal investigator
Children's Hospital of Philadelphia
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Acute Myeloid Leukemia, run by Children's Hospital of Philadelphia at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Issues Related to Type of Neutropenia Management That Are Most Important to Children and Their Caregivers. (time frame: One qualitative semi-structured interview was conducted post-neutropenia management. The interview lasted about 30-45 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.